BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIDI PRODUCTS, LLC GRIP-LOK

    MDR report key: 12549892 · Received September 29, 2021

    Report

    Report Number
    2182318-2021-00008
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Report Date
    August 27, 2021
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED FOR EVALUATION THEREFORE, THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. THERE WAS NO PATIENT OR CAREGIVER INJURY AND NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS RECEIVED FOR THIS LOT. HISTORICAL COMPLAINT DATA WAS REVIEWED AND FOUND FOUR TOTAL COMPLAINTS FOR SECUREMENT DEVICES FOR ADHESIVE THAT IS TOO STICKY SINCE 2018. THESE DEVICES HAVE A COMPLAINT RATE OF 0.007% FOR THIS FAILURE YEAR-TO-DATE. THE PRODUCT INSTRUCTIONS FOR USE WERE REVIEWED AND REDETERMINED TO PROVIDE SUFFICIENT INSTRUCTIONS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. SPECIFICALLY, LINE #1 OF THE INSTRUCTIONS STATES "CATHETER, TUBE OR LINE SHOULD BE ALREADY PLACED/INSERTED". THE COMPLAINT DESCRIPTION DESCRIBES "MOBILIZING THE PICC LINE". IF THE PICC LINE IS MOVED OR ADJUSTED, THIS COULD RESULT IN IMPROPER FUNCTION OF THE DEVICE. WITHOUT RETURN OF THE DEVICE, THE REPORTED ISSUE COULD NOT BE CONFIRMED. AT THIS TIME, THERE IS NOT ENOUGH EVIDENCE TO CONFIRM THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "WE RECEIVED NEW SCRATCH (VELCRO) GRIP LOCK. THEY ARE NOT PRACTICAL TO USE, THE SURFACE WHERE TO POSITION THE HUB OF THE PICCLINE IS TOO STICKY. IF WINGS OF HE HUB ARE POSISTIONED BADLY FROM THE START, TO REPOSITION IT, IT IS VERY DIFFICULT TO REMOVE IA AND THERE IS A BIG RISK OF THE PICC LINE COMING OUT. THE PAPERS TO BE REMOVED TO STICK THE BANDAGE TO THE SKIN ARE ALSO DIFFICULT TO USE AND TO REMOVE THEM PROPERLY IT IS NECESSARY TO MOBILIZE THE PICC LINE WITH THE RISK OF LEADING THE PICC LINE TO COME OUT. CONSEQUENCES DURING CHECKING OF MY LAST DRESSING, THE PICC LINE OF THE PATIENT SLIGHTLY WENT OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445956 TIDI PRODUCTS, LLC GRIP-LOK PICC / CVC SECUREMENT DEVICE WITH ADHESIVE KMK 3300MW-TA-3 46238225

    Patients

    Seq Age Sex Outcome Treatment
    1